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Completed

NCT Number: NCT01486862

Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs

This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pachuca, 42060, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes mellitus for at least 12 months
  • HbA1c between 7.5-14.5% (inclusive) at screening
  • Insulin naïve
  • An antidiabetic regimen that has been stable for at least 3 months prior to screening
  • An antidiabetic regimen that includes a minimum of 2 OADs

Exclusion criteria

  • Use of any insulin preparations within the past 6 months
  • Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening

Treatment and study plan

biphasic insulin aspart 30

Drug

Dose individually adjusted. Administered once daily for 16 weeks. If HbA1c after 16 weeks of treatment is above 7.0%, insulin is administered twice daily for additional 16 weeks.

Primary outcomes

  1. Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0%

Secondary outcomes

  1. Change in HbA1c

  2. Total number of hypoglycemic events

  3. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

NovoMix® 30 (Biphasic Insulin Aspart 70/30) Titrate-to-target: An Observational Study of the Efficacy of NovoMix® 30 in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Dec 7, 2011
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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